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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT01774487 |
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Date of registration:
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22/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pentoxifylline Therapy in Biliary Atresia
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Scientific title:
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A Phase II Trial of Pentoxifylline in Newly-Diagnosed Biliary Atresia |
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Date of first enrolment:
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February 4, 2013 |
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Target sample size:
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17 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01774487 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Sanjiv Harpavat, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 0-180 days old
- Diagnosed with biliary atresia through liver biopsy and/or intra-operative
cholangiogram
- No previous Kasai portoenterostomy performed at another institution
- Able to take medications orally
- Legal guardian signs consent after understanding risks and investigational nature of
study
Exclusion Criteria:
- Infants greater than 180 days old
- Infants receiving a Kasai portoenterostomy at another institution
- Infants unable to take medications orally
Age minimum:
N/A
Age maximum:
180 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Biliary Atresia
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Intervention(s)
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Drug: Pentoxifylline
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Primary Outcome(s)
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Number of Participants With Normal Serum Conjugated Bilirubin Levels 12 Weeks After Starting PTX (Pentoxifylline) Therapy
[Time Frame: 12 weeks after starting therapy]
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Secondary Outcome(s)
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Number of Participants Achieving Zero or Positive Weight Z-scores 12 Weeks After Starting PTX Therapy
[Time Frame: 12 weeks after starting therapy]
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Spleen Size at 2 Years of Age
[Time Frame: 2 years of age]
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Alanine Amino Transferase (ALT) Levels at 2 Years of Life
[Time Frame: 2 years of age]
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Platelet Levels at 2 Years of Life
[Time Frame: 2 years of age]
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Time to Liver Transplant
[Time Frame: Baseline and up to two years after therapy finishes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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